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NCT Number: NCT07486843

Preventing Structural Damage in Early Psoriatic Arthritis

Investigators hypothesize that TNFi is superior to SC MTX in preventing structural damage in early, treatment-naïve PsA, assessed using HR-pQCT. The study aims to ascertain:

- The effect of SC MTX and TNFi (adalimumab biosimilar) on erosion and enthesiophyte progression in early PsA by HR-pQCT.

Participants will be:

* Randomized in a 1:1 ratio to either the SC MTX group or the TNFi group. * HR-pQCT of MCPJ 2-4 will be performed at baseline, week 24, and one year.

The primary outcome is the comparison of change in erosion volume over MCPJ 2-4 across 48 weeks between the SC MTX group (group 1) and the TNFi group (group 2), assessed by HR-pQCT.

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Key information

Conditions

Psoriatic Arthritis (PsA) Arthritis Arthritis, Psoriatic Bone Diseases Joint Diseases Musculoskeletal Diseases Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Chinese University of Hong Kong, Prince of Wales Hospital

Hong Kong

Location status: Recruiting

Location contact

Prof. Tam

CONTACT

[email protected]

852-35051429

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years old
  • without severe deformity in MCPJ
  • with active disease, which is defined as ≥1 tender joints and ≥1 swollen joints, despite previous treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) for ≥ 4 weeks
  • with at least one poor prognostic factor (eg, polyarthritis, structural damage on HR-pQCT or CR, elevated acute phase reactants, dactylitis, nail involvement or HAQ-DI>1)
  • symptom duration ≤ 2 years

Exclusion criteria

  • on csDMARDs unless being prescribed for skin psoriasis (e.g. cyclosporin)
  • limited in ability to perform usual self-care, vocational, and avocational activities
  • pregnancy
  • previous therapy with b/tsDMARDs
  • predominant active axial PsA or significant uveitis/inflammatory bowel disease requiring immediate b/tsDMARDs therapy
  • the presence of active inflammatory diseases other than PsA
  • active infection in 2 weeks before randomization or a history of ongoing, chronic, or recurrent infections including tuberculosis
  • history of malignant disease within the past 5 years (excluding basal cell carcinoma or actinic keratosis, in-situ cervical cancer, or non-invasive malignant colon polyps)
  • contraindications to MTX or adalimumab

Treatment and study plan

Amgevita 40Mg Solution for Injection

Drug

Amgevita 40mg

Methotrexate (Metoject® prefilled pen)

Drug

Metoject® PEN 7.5 mg, Metoject® PEN 10 mg, Metoject® PEN 15 mg, Metoject® PEN 20 mg, Metoject® PEN 25 mg

Primary outcomes

  1. The change in erosion volume (mm³) in the MCPJ 2-4 over a period of 48 weeks between Group 1 (MTX) and Group 2 (TNFi group) assessed by HR-pQCT

    Time frame: 48 weeks

Secondary outcomes

  1. The change in erosion volume (mm³) in the MCPJ 2-4 over a period of 24 weeks

    Time frame: 24 weeks

  2. The proportion (in percentage) of erosions showing partial healing at weeks 24 and 48

    Time frame: Week 24 and 48

  3. The change in the enthesiophyte volume (mm³) at weeks 24 and 48

    Time frame: Weeks 24 and 48

  4. The proportion (in percentage) of enthesiophytes exhibiting progression at weeks 24 and 48

    Time frame: Week 24 and 48

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Methotrexate Versus TNF Inhibition in Preventing Structural Damage in Early Psoriatic Arthritis: A Randomized Trial Using HR-pQCT (MeTEPsA Trial)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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